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Biotech / Medical : Neotherapuetics possibly has a breakthrough drug - NEOT -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (198)5/9/2003 8:42:24 AM
From: Icebrg  Respond to of 204
 
Spectrum Pharmaceuticals Announces FDA Acceptance of ANDA Filing for Ciprofloxacin
Friday May 9, 8:31 am ET

IRVINE, Calif., May 9 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced that the US Food and Drug Administration (FDA) has accepted for filing its Abbreviated New Drug Application (ANDA) for ciprofloxacin. The filing was made by the Company's NeoJB subsidiary on behalf of J.B. Chemicals & Pharmaceuticals, Ltd. (Bombay Stock Exchange: JBCPL). Upon approval of the ANDA and expiration of the patent in December 2003, JBCPL will manufacture ciprofloxacin and NeoJB will market the drug in the United States. The Company hopes to generate revenue from the sale of ciprofloxacin in 2004.

"We are pleased with the FDA acceptance of the ANDA filing for our first generic drug, ciprofloxacin," stated Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "This ANDA acceptance is a significant milestone in our ongoing effort to build Spectrum Pharmaceuticals' generic drug business. While we await the FDA's action on our application for ciprofloxacin, we are working on our distribution and marketing arrangements, as well as at least two more additional ANDA filings planned for this year."

Last year, Spectrum and JBCPL formed NeoJB LLC to enable Spectrum to benefit from JBCPL's high quality, lower cost drug manufacturing capabilities through the sale of JBCPL's generic drugs in the United States. JBCPL will benefit from Spectrum's skills in managing the regulatory and marketing functions in the United States. NeoJB LLC is an 80% and 20% joint venture of Spectrum and a subsidiary of J.B. Chemicals & Pharmaceuticals Ltd. respectively.

JBCPL is an internationally known pharmaceutical company headquartered in Mumbai, India. Today, its products are marketed and well accepted in over 50 countries and it has 12 manufacturing facilities producing a diverse range of high quality bulk drugs for domestic use and as a supplier to international markets. They also sell intermediates, pharmaceutical specialties, radio- diagnostics, herbal remedies and generic drugs. JBCPL produces and markets a family of herbal products under the "Doktor Mom" label. Doktor Mom is the brand leader among cough remedies in Russia, and has been awarded the Reader's Digest Most Trusted European Brand Award for the past two years. In addition, JBCPL is actively involved in the research and development of new drug products, such as JB-7/G a cox-II inhibitor, which is expected to enter clinical development in the United States as an anti-inflammatory. For more information on JBCPL visit their website at www.uniquepharma.com .



To: Icebrg who wrote (198)5/14/2003 6:01:34 PM
From: Icebrg  Read Replies (1) | Respond to of 204
 
Spectrum Pharmaceuticals Receives Additional $1.56 Million in Financing
Wednesday May 14, 5:54 pm ET
Total of $6 Million Raised During the First Half of May 2003

IRVINE, Calif., May 14 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI - News) today announced that it has raised an additional $1.56 million through the sale of newly issued shares of Series D 8% Cumulative Convertible Preferred Stock to the same group of investors who participated in the financing that closed last week. The institutional investors are well known biotechnology investors, such as SCO Capital Partners, SDS Merchant Fund, Xmark Funds and ProMed Partners, L.P. This second closing brings total capital raised by Spectrum this month to $6 million.

"This additional investment by these investors reflects their confidence in our Company," stated Rajesh Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum. "Since we embarked on our oncology and generic drug strategy last August, we have now raised more than $8.0 million through the issuance of equity and received $2 million in licensing payments. These cash sources have enabled us to greatly improve our balance sheet and working capital and eliminate the "going concern" explanatory paragraph in the report of our independent auditor for the year ended December 31, 2002. With the additional milestone payments we expect from satraplatin and ciprofloxacin advancements this year, we believe that we now have resources in place to operate into the second half of next year."

The preferred stock is convertible into Spectrum common stock at a price of $2.35 per share. Dividends on the preferred stock are payable quarterly either in cash or common stock at the discretion of the Company. In addition, purchasers of the preferred stock in this second transaction received warrants to purchase 331,914 shares of common stock at $3.00 per share and 331,914 shares of common stock at $3.50 per share. If exercised, the warrants could generate up to an additional $2.2 million in proceeds to Spectrum. The common stock and warrants to purchase common stock have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States without a registration statement or exemption from registration.